BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 14911505 · Received July 4, 2022

    Report

    Report Number
    3017155477-2022-00004
    Event Type
    Injury
    Date Received
    July 4, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTORS OFFICE CALLED STATING THAT THE PATIENT HAD AN ALLERGIC REACTION DURING DUE TO THE USMILE ALIGNER. WHAT: THE PATIENT HAD AN ALLERGIC REACTION TO THE USMILE ALIGNER USED FOR TREATMENT AND HAD TO GO TO THE EMERGENCY ROOM AND USE AN EPI-PEN. WHEN: (B)(6) 2022. WHERE: THIS DOCTOR'S OFFICE NOTIFIED THE RSM (JOEL) TO REPORT THE PATIENT'S ALLERGIC REACTION. WHY: THE DOCTOR'S OFFICE STATED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ALIGNERS THAT CAUSED THE PATIENT TO USE AN EPI-PEN AND TO GO TO THE EMERGENCY ROOM. CLIENT SERVICES REPLIED VIA EMAIL TO BOTH THE RSM AND DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA FLX MATERIAL WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS AND THE MSDS SHEET FOR THE LIQUINOX CLEANER WHICH IS USED TO CLEAN THE USMILE ALIGNERS. CLIENT SERVICES ALSO ADVISED THAT THE PATIENT SHOULD ALSO BE TESTED FOR PRIMER/ETCH ADHESIVE AND ELASTICS (WHICH THE PATIENT IS WEARING). CLIENT SERVICES ALSO ASKED THE DOCTOR OFFICE THE FOLLOWING FIXE QUESTIONS: 1. WHAT IS THE PATIENTS' HEALTH OUTCOME? 2.DOES THIS PATIENT HAS ANY KNOWN ALLERGIES IF NOT WILL THEY BE GETTING ANY FURTHER TESTING FOR ALLERGIES? 3. DID THE PATIENT NEED MEDICAL ATTENTION LIKE MEDICATIONS OR SOMETHING ELSE TO RESOLVE THE ALLERGIC ISSUE? 4. IS THE ALLERGIC REACTION RESOLVED? 5. WOULD YOU LIKE TO REORDER AND SEE IF IT HAPPENS AGAIN OR PRINT IN HOUSE. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR'S OFFICE DID NOT RESPOND TO THE CLIENT SERVICES EMAIL WITH THE ABOVE QUESTIONS ASKING ABOUT THE PATIENT'S HEALTH/KNOWN ALLERGIES/MEDICAL ATTENTION/ALLERGIC REACTION RESOLUTION. IT IS NOT KNOWN IF THE ALIGNER MATERIAL (ZENDURA FLX) OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. T ADDITIONALLY, RMA-0119 AND FEDEX TRACKING # (B)(4) SHOWS NO MOVEMENT SINCE 06/06/2022. PER SOP0073, RETURNED MATERIALS AUTHORIZATION, SECTION 6.7 RMA-0119 WILL BE CLOSED AS PRODUCT WAS NOT RETURNED TO ULAB SYSTEMS FOR INVESTIGATION/REVIEW.

    Description of Event or Problem · 0

    ON 06/06/2022, THE DOCTORS OFFICE NOTIFIED THE RSM TO REPORT A PATIENT'S ALLERGIC REACTION- STATING THAT THE PATIENT HAD AN ALLERGIC REACTION DUE TO THE USMILE ALIGNER USED FOR TREATMENT AND HAD TO GO TO THE EMERGENCY ROOM AND USE AN EPI-PEN. THE DOCTOR'S OFFICE STATED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE ALIGNERS THAT CAUSED THE PATIENT TO USE AN EPI-PEN AND TO GO TO THE EMERGENCY ROOM. CLIENT SERVICES REPLIED VIA EMAIL TO BOTH THE RSM AND DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ZENDURA FLX MATERIAL WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS AND THE MSDS SHEET FOR THE LIQUINOX CLEANER WHICH IS USED TO CLEAN THE USMILE ALIGNERS. CLIENT SERVICES ALSO ADVISED THAT THE PATIENT SHOULD ALSO BE TESTED FOR PRIMER/ETCH ADHESIVE AND ELASTICS (WHICH THE PATIENT IS WEARING). CLIENT SERVICES ALSO ASKED THE DOCTOR OFFICE THE FOLLOWING FIXE QUESTIONS: 1. WHAT IS THE PATIENTS' HEALTH OUTCOME? 2.DOES THIS PATIENT HAS ANY KNOWN ALLERGIES IF NOT WILL THEY BE GETTING ANY FURTHER TESTING FOR ALLERGIES? 3. DID THE PATIENT NEED MEDICAL ATTENTION LIKE MEDICATIONS OR SOMETHING ELSE TO RESOLVE THE ALLERGIC ISSUE? 4. IS THE ALLERGIC REACTION RESOLVED? 5. WOULD YOU LIKE TO REORDER AND SEE IF IT HAPPENS AGAIN OR PRINT IN HOUSE. CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR'S OFFICE DID NOT RESPOND TO THE CLIENT SERVICES EMAIL WITH THE ABOVE QUESTIONS ASKING ABOUT THE PATIENT'S HEALTH/KNOWN ALLERGIES/MEDICAL ATTENTION/ALLERGIC REACTION RESOLUTION. IT IS NOT KNOWN IF THE ALIGNER MATERIAL (ZENDURA FLX) OR OTHER MATERIALS USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. ADDITIONALLY, RMA-0119 AND FEDEX TRACKING # (B)(4) SHOWS NO MOVEMENT SINCE (B)(6) 2022. PER SOP0073, RETURNED MATERIALS AUTHORIZATION, SECTION 6.7 RMA-0119 WILL BE CLOSED AS PRODUCT WAS NOT RETURNED TO ULAB SYSTEMS FOR INVESTIGATION/REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397899 ULAB SYSTEMS DENTAL ALIGNER FG0094, ULAB SYSTEMS ALIGNER KIT NXC ULAB SYSTEMS FG0094 EEB08

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Prefer Not To Disclose Other FG0094, ULAB SYSTEMS USMILE ALIGNER KIT